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Albuferon(R) (albumin-interferon alpha 2b), a novel long-acting form of interferon alpha for the treatment of chronic hepatitis C
At the 900-mcg dose now being studied in Phase 3, Albuferon requires half as many injections as Pegasys (peginterferon alfa-2a). Final Phase 2b results in treatment-naive patients, presented in November 2007 at the Annual Meeting of the American Association for the Study of Liver Diseases, demonstrated that the 900-mcg dose of Albuferon every two weeks provided efficacy comparable to Pegasys, with comparable safety, the potential for less impairment of health-related quality of life on treatment, and significantly fewer working patients reporting missed days of work. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
Recent progress: In April 2008, HGS completed the treatment phase of
ACHIEVE 2/3, one of two Phase 3 trials of Albuferon (albinterferon alfa-2b)
in combination with ribavirin in treatment-naive patients with chronic
hepatitis C. The Company expects to complete the treatment phase of ACHIEVE
1 in July 2008. Data were presented in April 2008 at the Annual Meeting of
the European Association for the Study of the Liver, which showed that
Albuferon's pharmacodynamic characteristics and ability to maintain
effective blood levels for a longer period of time than is seen with other
long-acting interferons may make it an effective component of future
combination treatment with novel antivirals for the treatment of chronic
hepatitis C.
Key milestones leading to a potential launch of Albuferon in 2010:
-- Complete the treatment phase of ACHIEVE 1, the Phase 3 trial in
genotype 1 chronic hepatitis C, in July 2008.
-- First Phase 3 data available before the end of 2008 (from ACHIEVE 2/3,
the trial in genotypes 2 and 3 chronic hepatitis C).
-- All Phase 3 data ava
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